Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance in Older People
Dunhill01
1 other identifier
interventional
50
1 country
1
Brief Summary
With age, muscles tend to waste at 0.5-1% per year, so that an 80 year old may have only 70% of the muscle possessed at 50. Muscle loss makes it harder to carry out tasks that require strength, keep the body balanced and continue activity for a prolonged period, which together may contribute to a loss of independence and an increased risk of falls. The cause of some of this muscle loss with ageing appears to be a reduction in muscle building in response to food. The known decreased limb blood flow in ageing muscle may go some way to explain this as there may be less nutrient delivery to the muscles. The investigators want to test if the known decrease in limb blood flow with age is matched with a decrease in the proportion of blood being delivered directly to the muscles, rather than fat and connective tissue. If so the investigators expect to see an improvement in the ability of muscles to maintain themselves via better capture of amino acids into protein. The investigators also want to test if 20 weeks resistance exercise training or drinking a cocktail of mixture of high flavanol cocoa (which can increase blood flow) and vitamin C can improve limb blood flow to older muscles and help reduce muscle wasting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 21, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedNovember 28, 2012
November 1, 2012
2.9 years
November 21, 2012
November 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microvascular blood volume in response to feeding
The final study participant was completed and all microvascular blood volume data analysed by August 2012. This outcome measure is applicable to all arms of this study and refers to responsiveness to a 2 hour feed protocol.
September 2009 - August 2012
Secondary Outcomes (1)
Muscle protein metabolism in response to feeding
January - October 2012
Other Outcomes (1)
Molecular pathways regulating muscle microvascular blood volume
August 2012 - August 2013
Study Arms (5)
Young
NO INTERVENTIONYoung subjects to be controlled to older individuals with interventions
Old
NO INTERVENTIONOlder individuals to compare to young and other older intervention groups
Old Exercise
EXPERIMENTALOlder individuals studied after an intervention of 20 weeks fully-supervised resistance exercise training
Old Acute Cocoa
EXPERIMENTALOlder individuals studied with the addition of cocoa flavanols during their acute study
Old 7 Day Cocoa
EXPERIMENTALOlder individuals studied after 7 day supplementation of cocoa flavanols
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers aged 18-28 or 65-75
You may not qualify if:
- Overt muscle wasting i.e. muscle mass is more than 1 standard deviation below normal muscle or FFM for age
- A BMI \< 24 or \> 28 kg•m2.
- Active cardiovascular disease: uncontrolled hypertension (BP \> 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event
- Individuals taking beta-adrenergic blocking agents.
- Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial).
- Respiratory disease including pulmonary hypertension, COPD, asthma or an FEV1 less than 1.5 l.
- Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes.
- Active inflammatory bowel disease, or renal disease,
- Malignancy
- Recent steroid treatment (within 6 mo), or hormone replacement therapy.
- Clotting dysfunction
- Musculoskeletal or neurological disorders.
- Family history of early (\<55y) death from cardiovascular disease
- Known sensitivity to Definity or methacholine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- The Dunhill Medical Trustcollaborator
Study Sites (1)
Clinical Physiology Laboratory, Graduate Entry Medical School, University of Nottingham, Royal Derby Hospital
Derby, Derbyshire, DE22 3DT, United Kingdom
Related Publications (1)
Phillips B, Williams J, Atherton P, Smith K, Hildebrandt W, Rankin D, Greenhaff P, Macdonald I, Rennie MJ. Resistance exercise training improves age-related declines in leg vascular conductance and rejuvenates acute leg blood flow responses to feeding and exercise. J Appl Physiol (1985). 2012 Feb;112(3):347-53. doi: 10.1152/japplphysiol.01031.2011. Epub 2011 Oct 13.
PMID: 21998269BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John P Williams, PhD, MD
University of Nottingham
- STUDY DIRECTOR
Bethan E Phillips, PhD
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2012
First Posted
November 27, 2012
Study Start
September 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
November 28, 2012
Record last verified: 2012-11